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Open Access 01-12-2022 | Pyloromyotomy | Study protocol

Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial

Authors: Matthias C. Schrempf, David R. M. Pinto, Sebastian Wolf, Bernd Geissler, Florian Sommer, Michael Hoffmann, Dmytro Vlasenko, Johanna Gutschon, Matthias Anthuber

Published in: Trials | Issue 1/2022

Abstract

Background

Pylorus-preserving pancreaticoduodenectomy (ppPD) is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region. One of the most common postoperative complications after ppPD is delayed gastric emptying (DGE) which reduces quality of life, prevents a timely return to a solid oral diet and prolongs the length of hospital stay. In a retrospective analysis, intraoperative endoluminal pyloromyotomy was associated with a reduced rate of DGE. The aim of this study is to investigate the effect of intraoperative endoluminal pyloromyotomy on postoperative DGE after ppPD in a randomised and controlled setting.

Methods

This randomised trial features parallel group design with a 1:1 allocation ratio and a superiority hypothesis. Patients with a minimum age of 18 years and an indication for ppPD are eligible to participate in this study and will be randomised intraoperatively to receive either endoluminal pyloromyotomy or atraumatic stretching of the pylorus. The sample size calculation (n=64 per study arm) is based on retrospective data. The primary endpoint is the rate of DGE within 30 days. Secondary endpoints are quality of life, operation time, estimated blood loss, length of hospital stay, morbidity and mortality.

Discussion

DGE after ppPD is a common complication with an incomplete understood aetiology. Prevention of DGE could improve outcomes and enhance quality of life after one of the most common procedures in pancreatic surgery. This trial will expand the existing evidence on intraoperative pyloromyotomy, and the results will provide additional data on a simple surgical technique that could reduce the incidence of postoperative DGE.

Trial registration

German Clinical Trials RegisterDRKS00013503. Registered on 27 December 2017.

Traverso LW, Longmire WP Jr. Preservation of the pylorus in pancreaticoduodenectomy. Surg Gynecol Obstet. 1978;146(6):959–62.PubMed

Huttner FJ, et al. Pylorus-preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma. Cochrane Database Syst Rev. 2016;2(5):CD006053. https://doi.org/10.1002/14651858.CD006053.pub6.CrossRefPubMed

Diener MK, Knaebel HP, Heukaufer C, Antes G, Büchler MW, Seiler CM. A systematic review and meta-analysis of pylorus-preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma. Ann Surg. 2007;245(2):187–200. https://doi.org/10.1097/01.sla.0000242711.74502.a9.CrossRefPubMedPubMedCentral

Eshuis WJ, van Eijck CHJ, Gerhards MF, Coene PP, de Hingh IHJT, Karsten TM, et al. Antecolic versus retrocolic route of the gastroenteric anastomosis after pancreatoduodenectomy: a randomized controlled trial. Ann Surg. 2014;259(1):45–51. https://doi.org/10.1097/SLA.0b013e3182a6f529.CrossRefPubMed

Eshuis WJ, de Bree K, Sprangers MAG, Bennink RJ, van Gulik TM, Busch ORC, et al. Gastric emptying and quality of life after pancreatoduodenectomy with retrocolic or antecolic gastroenteric anastomosis. Br J Surg. 2015;102(9):1123–32. https://doi.org/10.1002/bjs.9812.CrossRefPubMed

Eisenberg JD, Rosato EL, Lavu H, Yeo CJ, Winter JM. Delayed Gastric Emptying After Pancreaticoduodenectomy: an Analysis of Risk Factors and Cost. J Gastrointest Surg. 2015;19(9):1572–80. https://doi.org/10.1007/s11605-015-2865-5.CrossRefPubMed

Warshaw AL, Torchiana DL. Delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy. Surg Gynecol Obstet. 1985;160(1):1–4.PubMed

Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142(5):761–8. https://doi.org/10.1016/j.surg.2007.05.005.CrossRefPubMed

Kim DK, Hindenburg AA, Sharma SK, Suk CH, Gress FG, Staszewski H, et al. Is pylorospasm a cause of delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy? Ann Surg Oncol. 2005;12(3):222–7. https://doi.org/10.1245/ASO.2005.03.078.CrossRefPubMed

10.

Ohtsuka T, Takahata S, Ohuchida J, Takeda T, Matsunaga H, Yokohata K, et al. Gastric phase 3 motility after pylorus-preserving pancreatoduodenectomy. Ann Surg. 2002;235(3):417–23. https://doi.org/10.1097/00000658-200203000-00014.CrossRefPubMedPubMedCentral

11.

Takahata S, Ohtsuka T, Nabae T, Matsunaga H, Yokohata K, Yamaguchi K, et al. Comparison of recovery of gastric phase III motility and gastric juice output after different types of gastrointestinal reconstruction following pylorus-preserving pancreatoduodenectomy. J Gastroenterol. 2002;37(8):596–603. https://doi.org/10.1007/s005350200095.CrossRefPubMed

12.

Gauvin JM, Sarmiento JM, Sarr MG. Pylorus-preserving pancreaticoduodenectomy with complete preservation of the pyloroduodenal blood supply and innervation. Arch Surg. 2003;138(11):1261–3. https://doi.org/10.1001/archsurg.138.11.1261.CrossRefPubMed

13.

Welsch T, Borm M, Degrate L, Hinz U, Büchler MW, Wente MN. Evaluation of the International Study Group of Pancreatic Surgery definition of delayed gastric emptying after pancreatoduodenectomy in a high-volume centre. Br J Surg. 2010;97(7):1043–50. https://doi.org/10.1002/bjs.7071.CrossRefPubMed

14.

Park JS, Hwang HK, Kim JK, Cho SI, Yoon DS, Lee WJ, et al. Clinical validation and risk factors for delayed gastric emptying based on the International Study Group of Pancreatic Surgery (ISGPS) Classification. Surgery. 2009;146(5):882–7. https://doi.org/10.1016/j.surg.2009.05.012.CrossRefPubMed

15.

Parmar AD, Sheffield KM, Vargas GM, Pitt HA, Kilbane EM, Hall BL, et al. Factors associated with delayed gastric emptying after pancreaticoduodenectomy. HPB (Oxford). 2013;15(10):763–72. https://doi.org/10.1111/hpb.12129.CrossRef

16.

Fischer CP, Hong JC. Method of pyloric reconstruction and impact upon delayed gastric emptying and hospital stay after pylorus-preserving pancreaticoduodenectomy. J Gastrointest Surg. 2006;10(2):215–9. https://doi.org/10.1016/j.gassur.2005.07.017.CrossRefPubMed

17.

Kurahara H, Shinchi H, Maemura K, Mataki Y, Iino S, Sakoda M, et al. Delayed gastric emptying after pancreatoduodenectomy. J Surg Res. 2011;171(2):e187–92. https://doi.org/10.1016/j.jss.2011.08.002.CrossRefPubMed

18.

Hanna MM, Tamariz L, Gadde R, Allen C, Sleeman D, Livingstone A, et al. Delayed gastric emptying after pylorus preserving pancreaticoduodenectomy - Does gastrointestinal reconstruction technique matter? Am J Surg. 2016;211(4):810–9. https://doi.org/10.1016/j.amjsurg.2015.10.015.CrossRefPubMed

19.

Qian D, Lu Z, Jackson R, Wu J, Liu X, Cai B, et al. Effect of antecolic or retrocolic route of gastroenteric anastomosis on delayed gastric emptying after pancreaticoduodenectomy: A meta-analysis of randomized controlled trials. Pancreatology. 2016;16(1):142–50. https://doi.org/10.1016/j.pan.2015.11.003.CrossRefPubMed

20.

Hackert T, Probst P, Knebel P, Doerr-Harim C, Bruckner T, Klaiber U, et al. Pylorus Resection Does Not Reduce Delayed Gastric Emptying After Partial Pancreatoduodenectomy: A Blinded Randomized Controlled Trial (PROPP Study, DRKS00004191). Ann Surg. 2018;267(6):1021–7. https://doi.org/10.1097/SLA.0000000000002480.CrossRefPubMed

21.

Huttner FJ, et al. Antecolic versus retrocolic reconstruction after partial pancreaticoduodenectomy. Cochrane Database Syst Rev. 2016;9(9):CD011862. https://doi.org/10.1002/14651858.CD011862.pub2.CrossRefPubMed

22.

Klaiber U, Probst P, Strobel O, Michalski CW, Dörr-Harim C, Diener MK, et al. Meta-analysis of delayed gastric emptying after pylorus-preserving versus pylorus-resecting pancreatoduodenectomy. Br J Surg. 2018;105(4):339–49. https://doi.org/10.1002/bjs.10771.CrossRefPubMed

23.

Geyl S, Legros R, Charissou A, Mesturoux L, Couquet CY, Carrier P, et al. Peroral endoscopic pyloromyotomy accelerates gastric emptying in healthy pigs: proof of concept. Endosc Int Open. 2016;4(7):E796–9. https://doi.org/10.1055/s-0042-108192.CrossRefPubMedPubMedCentral

24.

Su A, Conklin JL, Sedarat A. Endoscopic Therapies for Gastroparesis. Curr Gastroenterol Rep. 2018;20(6):25. https://doi.org/10.1007/s11894-018-0630-0.CrossRefPubMed

25.

Grover M, Farrugia G, Stanghellini V. Gastroparesis: A turning point in understanding and treatment. BMJ Publ Group. 2019;(12):2238–50. https://doi.org/10.1136/gutjnl-2019-318712.

26.

Khashab MA, Ngamruengphong S, Carr-Locke D, Bapaye A, Benias PC, Serouya S, et al. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017;85(1):123–8. https://doi.org/10.1016/j.gie.2016.06.048.CrossRefPubMed

27.

Schrempf MC, Pinto DRM, Gutschon J, Schmid C, Hoffmann M, Geissler B, et al. Intraoperative endoluminal pyloromyotomy as a novel approach to reduce delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy-a retrospective study. Langenbecks Arch Surg. 2020;406(4):1103–10. https://doi.org/10.1007/s00423-020-02008-5.CrossRefPubMedPubMedCentral

28.

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13.CrossRef

29.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76. https://doi.org/10.1093/jnci/85.5.365.CrossRef

30.

Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995;311(7013):1145–8. https://doi.org/10.1136/bmj.311.7013.1145.CrossRefPubMedPubMedCentral

31.

Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rdEdition). Published by: European Organisation for Research and Treatment of Cancer, Brussels, 2001, ISBN 2-9300 64-22-6, p. 5-15.

32.

Matsumoto I, Shinzeki M, Asari S, Goto T, Shirakawa S, Ajiki T, et al. A prospective randomized comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying occurrence and long-term nutritional status. J Surg Oncol. 2014;109(7):690–6. https://doi.org/10.1002/jso.23566.CrossRefPubMed

33.

Shrestha A, Martin C, Burton M, Walters S, Collins K, Wyld L. Quality of life versus length of life considerations in cancer patients: A systematic literature review. Psychooncology. 2019;28(7):1367–80. https://doi.org/10.1002/pon.5054.CrossRefPubMedPubMedCentral

Title: Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial
Authors: Matthias C. Schrempf
David R. M. Pinto
Sebastian Wolf
Bernd Geissler
Florian Sommer
Michael Hoffmann
Dmytro Vlasenko
Johanna Gutschon
Matthias Anthuber
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Pyloromyotomy
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06032-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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